MAUDE Adverse Event Report: ORTHOFIX SRL AGILE NAIL TI NAIL LEFT L380MM D10MM STERILE

Model Number	AGILE NAIL
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in this event has not been returned for investigation as it was implanted.It has been requested to return the packaging involved.If the packaging is returned an investigation will be completed and a follow up report will be submitted.As per instructions for use in general warnings and in general precautions: -do not use if packaging is compromised or if a component is believed to be faulty, damaged or suspect.-examine all components carefully prior to use.Product integrity, sterility (in the case of sterile products) and performance are assured only if the packaging is undamaged.For sterile products: devices or kits provided sterile are labeled as such.Contents of package are sterile unless package is opened or damaged.Do not use if package is opened or damaged.
Event or Problem Description
It was reported that during a surgery the external packaging of an agile nail was intact, while the internal primary blister was pierced.The device was implanted.Manufacturer ref: (b)(4).Initial reporter ref: (b)(4).
Additional Manufacturer Narrative
Technical analysis: the impacted device is packaged within two sterile pouches and an external carton box, to which the product label is applied.Upon return, only the inner sterile pouch and the external carton box were received; the outer sterile pouch, which had been originally verified as conforming, was missing.Visual inspection confirmed the alleged malfunction.The returned package showed a hole in the inner sterile pouch.The external carton box was found to be intact, with no visible signs of damage or irregularities.During internal quality controls, 100% visual check of the material and the product was carried out both before and after sealing the pouches.Analysis of manufacturing records confirmed that the noticed device was released as conforming according to specifications.A review of similar cases involving agile products was conducted, and no other complaints have been registered in the last 12 months.Thus, this case is isolated.Conclusions based on the findings outlined above, the investigation was unable to determine the definitive root cause of the reported issue.Orthofix maintains and documents a periodic customer events monitoring process in order to evaluate actions for products improvement.As per instructions for use in general warnings and in general precautions: do not use if packaging is compromised or if a component is believed to be faulty, damaged or suspect.Examine all components carefully prior to use.Product integrity, sterility (in the case of sterile products) and performance are assured only if the packaging is undamaged.For sterile products: devices or kits provided sterile are labeled as such.Contents of package are sterile unless package is opened or damaged.Do not use if package is opened or damaged.
Event or Problem Description
It was reported that during a surgery the external packaging of an agile nail was intact, while the internal primary blister was pierced.The device was implanted.Initial reporter ref: (b)(4).

• Brand Name: AGILE NAIL TI NAIL LEFT L380MM D10MM STERILE
• Common Device Name: AGILE NAIL TI NAIL LEFT L380MM D10MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 21992313
• Report Number: 9680825-2025-00016
• Device Sequence Number: 4263502
• Product Code: HSB
• UDI-Device Identifier: 18054242519935
• UDI-Public: 18054242519935
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AGILE NAIL
• Device Catalogue Number: 99-T830380L
• Device Lot Number: B1495361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown